Ended Therapeutic exploratory (Phase II) Chronic hepatitis B

A trial to evaluate safety and characteristics of a substance for treatment of chronic hepatitis

EU CTIS ID: 2023-503880-40-00

What this study is testing

To evaluate the safety and efficacy of RBD1016 injection in participants with CHB on nucleoside analogues (NAs) background treatment. The trial is a multi-center, randomized, double-blind, placebo-controlled clinical study trial to assess the safety, efficacy, PK and immunogenicity of RBD1016 injection combined with NAs in CHB participants. The study trial contains screening period, treatment period and follow-up period. The trial is divided into 3 dose groups: 100 mg Q4W, 200 mg Q4W, and 200 mg Q12W. Each group will enroll 16 eligible participants, with 36 participants receiving RBD1016 injection and 12 participants receiving placebo.

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1) Willing and able to give written informed consent for trial participation;
10) Liver transient elastography (FibroScan) results within 12 months before screening or at screening showing that the liver stiffness measurement (LSM) level is less than 9 kPa; or with liver biopsy within 24 months before screening showing that the Metavir score is F0-F2;
11) For females with child-bearing potential: must be non-pregnant and non-lactating; the participant is using a highly effective contraceptive method for at least one month before screening and agree contraception during the trial period;
12) For males with child-bearing potential: the participant agrees contraception to ensure effective contraception for his sexual partner during the trial period.
2) Male or female participants aged 18-65 years;
3) Body mass index (BMI) within the range of 18-34 kilograms/square meter (kg/m2);

You likely can't join if

1) Laboratory results at screening as follows: serum/plasma alpha-fetoprotein (AFP) >50 μg/L; serum/plasma albumin concentration <3.0 g/dL; international normalized ratio (INR) >1.5; serum/plasma platelet count <90×109/L; serum/plasma direct bilirubin (DB) >2×ULN; serum/plasma creatinine concentration >1.5×ULN or creatinine clearance <60 mL/min (according to the Cockcroft-Gault equation); or any clinically significant laboratory outliers that the investigator believes may interfere with the interpretation of the efficacy and safety data in this trial;
18) Excessive alcohol drinking or abuse within 6 months before screening (for males: more than 14 standard units per week, and for females: more than 9 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of spirits of 40 % alcohol or 150 mL of wine) which in the investigator’s opinion that it is not appropriate to participate in this trial;
19) Drug users/drug abusers at 6 months before screening, and those who are proven to be drug abusers by reasonable evidence (at the discretion of the investigator);
2) Concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV), or diagnosis of syphilis, acute hepatitis A or acute hepatitis E;
20) Those who the investigator believes are not suitable to participate in the trial due to other factors.
3) Diagnosed with other liver diseases other than hepatitis B, including: autoimmune liver disease (autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis), inherited metabolic liver disease (hemochromatosis, Wilson’s disease, familial intrahepatic cholestasis, etc.), drug-induced liver disease and moderate or above non-alcoholic steatohepatitis (NASH), and the investigator believes that they are not suitable to participate in this trial;

See the full eligibility criteria

Who can join

1) Willing and able to give written informed consent for trial participation;
10) Liver transient elastography (FibroScan) results within 12 months before screening or at screening showing that the liver stiffness measurement (LSM) level is less than 9 kPa; or with liver biopsy within 24 months before screening showing that the Metavir score is F0-F2;
11) For females with child-bearing potential: must be non-pregnant and non-lactating; the participant is using a highly effective contraceptive method for at least one month before screening and agree contraception during the trial period;
12) For males with child-bearing potential: the participant agrees contraception to ensure effective contraception for his sexual partner during the trial period.
2) Male or female participants aged 18-65 years;
3) Body mass index (BMI) within the range of 18-34 kilograms/square meter (kg/m2);
4) Documented history of chronic hepatitis B virus (HBV) infection, by positive HBsAg and/or HBV DNA tests ≥ 6 months before screening;
5) HBeAg positive or negative at screening;
6) On a stable regimen (≥ 12 months before screening) of any approved first-line oral NAs;
7) HBV DNA level <100 IU/mL at screening;
8) HBsAg level ≥50 IU/mL at screening;
9) Serum/plasma alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of normal (ULN);

What rules you out

1) Laboratory results at screening as follows: serum/plasma alpha-fetoprotein (AFP) >50 μg/L; serum/plasma albumin concentration <3.0 g/dL; international normalized ratio (INR) >1.5; serum/plasma platelet count <90×109/L; serum/plasma direct bilirubin (DB) >2×ULN; serum/plasma creatinine concentration >1.5×ULN or creatinine clearance <60 mL/min (according to the Cockcroft-Gault equation); or any clinically significant laboratory outliers that the investigator believes may interfere with the interpretation of the efficacy and safety data in this trial;
18) Excessive alcohol drinking or abuse within 6 months before screening (for males: more than 14 standard units per week, and for females: more than 9 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of spirits of 40 % alcohol or 150 mL of wine) which in the investigator’s opinion that it is not appropriate to participate in this trial;
19) Drug users/drug abusers at 6 months before screening, and those who are proven to be drug abusers by reasonable evidence (at the discretion of the investigator);
2) Concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV), or diagnosis of syphilis, acute hepatitis A or acute hepatitis E;
20) Those who the investigator believes are not suitable to participate in the trial due to other factors.
3) Diagnosed with other liver diseases other than hepatitis B, including: autoimmune liver disease (autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis), inherited metabolic liver disease (hemochromatosis, Wilson’s disease, familial intrahepatic cholestasis, etc.), drug-induced liver disease and moderate or above non-alcoholic steatohepatitis (NASH), and the investigator believes that they are not suitable to participate in this trial;
4) History of liver cirrhosis or hepatic decompensation (e.g., ascites, varices bleeding, or hepatic encephalopathy) before or at screening;
5) History of organ transplantation or hepatocellular carcinoma (HCC);
6) History of COVID-19 within one month before screening;
7) Any serious or active disease other than liver disease that the investigator believes may interfere with the participant’s treatment, evaluation or compliance with the trial protocol, including any uncontrolled clinically significant renal, cardiac, pulmonary, thyroid, vascular, neurogenic, digestive, and metabolic disease;
8) History of immune-associated diseases (for example: idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis, autoimmune hemolytic anemia, severe psoriasis, or any other autoimmune disease);
10) Severe mental illness or uncontrolled current mental disorders, including but not limited to schizophrenia, bipolar disorder, or depression, which makes the participant not suitable for trial participation in opinion of the investigator;
9) History of malignant tumor within 5 years before screening, excluding special tumors cured by surgery (such as basal skin cancer);
11) Abnormal and clinically significant 12-lead ECG test results at screening such as QTcB/QTcF male>470ms, female>480ms, or other clinically significant abnormalities, which makes the participant not suitable for trial participation in opinion of the investigator;
12) Participants who have undergone major surgery within 6 months before screening;
13) Participants with serious infection, trauma or surgery within 4 weeks before screening, or those who plan to undergo surgery during the trial;
14) Participants with severe allergic constitution (allergic to multiple drugs and food), or with clear allergy to this product or its preparation ingredients which makes the participant not suitable for trial participation in opinion of the investigator;
15) History of severe hypersensitivity to subcutaneous injections (mild reactions are allowed, such as local swelling or redness);
16) Use of immunomodulators (thymosin, interleukin-2, levamisole, systemic corticosteroids, etc.) and/or cytotoxic drugs within 6 months prior to screening;
17) Enrollment in any other clinical trial involving drugs within 1 month prior to IMP administration or within 5 half-lives of other drugs, or have previously participated in clinical trials of similar anti-HBV siRNA or antisense oligonucleotide drugs, or have participated in clinical trials of anti-HBV drugs within 6 months before screening (if participants withdraw from that trial before treatment, that is, they are not randomized or receive no treatment, they can be screened in this trial);

The study team makes the final eligibility decision.

Where it's taking place

China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

Obesity Type 2 diabetes Type 1 diabetes Prediabetes Weight loss Metabolic syndrome High cholesterol High triglycerides High blood pressure PCOS Hypothyroidism Thyroid disease Gout Fatty liver disease (NAFLD/NASH)Heart failure Coronary artery disease

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.